NEUROvascular NAVgation With Remotely Controlled Deflectable Guidewire, Study I (NeuroNAV Study I)

Artiria Medical

Status

Not yet enrolling

Conditions

Unruptured Cerebral Aneurysm

Treatments

Device: Any standard of care guidewire

Device: SmartGUIDE (deflectable guidewire)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06972953

FR 2024

Details and patient eligibility

About

The aim of the study is to confirm the safe and successful use of the SmartGUIDE guidewire, when used in neuro interventions. The performance of the SmartGUIDE guidewire in terms of safe and successful navigation within the neurovasculature will be compared to standard of care guidewire on the market.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

>18 years of age
Informed consent signed by the patient
Confirmed cerebral unruptured aneurysm treatable via transcatheter approach

Exclusion criteria

Pregnancy or lactation
Known disorder of vascular fragility with propensity to vascular injury (e.g., Ehlers-Danlos syndrome)
Known prior vascular stenosis or dissection or injury to vessels intended to be catheterized during study procedures
Acute phase myocardial infarction or uncontrolled cardiac arrhythmia
Uncontrolled serum electrolyte imbalance
Bleeding disorder which limits the use of antiplatelet and/or anticoagulant therapy
Known contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication
Known hypersensitivity to Nickel
Subjects currently enrolled in another investigational device or drug study that clinically interferes with the current study endpoints